Back to resultsGemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Terminated
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Z650
Gemcitabine
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
Inclusion Criteria:
18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.
Exclusion Criteria:
adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction < 50%
Sites / Locations
- Jiangsu Province Hospital
- shandong Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
z650 and Gemcitabine
Arm Description
Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles
Outcomes
Primary Outcome Measures
Rate of dose limiting toxicities of each subject
Rate will be assessed through summaries of adverse events, clinical laboratory abnormalities, and changes in physical exam and vital signs. All subjects who receive a single dose of study medication will be considered evaluable for safety.
Secondary Outcome Measures
Adverse events related to pulse dose Z650 and gemcitabine
description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v5.0]), severity, seriousness, and relatedness
Overall response rate (ORR)
Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1
Disease Control Rate (DCR)
DCR, proportion of patients with best overall response of CR, PR or stable disease (SD)
Duration of Response (DOR)
DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause
Progression-free Survival (PFS)
PFS, defined as time from date of treatment to disease progression or death due to any cause
Overall Survival (OS)
OS, defined as time from date of treatment to death due to any cause
Full Information
NCT ID
NCT04131192
First Posted
October 10, 2019
Last Updated
May 4, 2022
Sponsor
Sunshine Lake Pharma Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04131192
Brief Title
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
Official Title
A Phase Ib, Multi-center, Open-label Study of Z650 and Gemcitabine in Advanced Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Terminated
Why Stopped
Combined with the analysis of the existing data of the trial, there was no obvious advantage compared with the clinical standard treatments, and the clinical trial was decided to be terminated based on the benefit of the subjects.
Study Start Date
November 11, 2019 (Actual)
Primary Completion Date
September 9, 2021 (Actual)
Study Completion Date
September 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunshine Lake Pharma Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.
Detailed Description
This phase IB trial is studying how well giving gemcitabine together with Z650 works in treating patients with metastatic or recurrent pancreatic cancer.This phase IB trial is Multi-center and open。
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
z650 and Gemcitabine
Arm Type
Experimental
Arm Description
Z650:250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal Gemcitabine: intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle FOR the 4-6 cycles
Intervention Type
Drug
Intervention Name(s)
Z650
Other Intervention Name(s)
larotinib
Intervention Description
250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemzar
Intervention Description
Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle ，for 4-6 cycles
Primary Outcome Measure Information:
Title
Rate of dose limiting toxicities of each subject
Description
Rate will be assessed through summaries of adverse events, clinical laboratory abnormalities, and changes in physical exam and vital signs. All subjects who receive a single dose of study medication will be considered evaluable for safety.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Adverse events related to pulse dose Z650 and gemcitabine
Description
description, timing, grade (Common Terminology Criteria for Adverse Events Version 5.0 [CTCAE v5.0]), severity, seriousness, and relatedness
Time Frame
up to 4 weeks after last dose
Title
Overall response rate (ORR)
Description
Overall response rate (ORR), defined as a partial response (PR) or complete response (CR) occurring at any point post-treatment according to Response Evaluation Criteria in Solid Tumors as assessed by RECIST v1.1
Time Frame
up to approximately 24 months
Title
Disease Control Rate (DCR)
Description
DCR, proportion of patients with best overall response of CR, PR or stable disease (SD)
Time Frame
up to approximately 24 months
Title
Duration of Response (DOR)
Description
DOR, defined as time from the first documented CR or PR to first documented progression or death due to any cause
Time Frame
up to approximately 24 months
Title
Progression-free Survival (PFS)
Description
PFS, defined as time from date of treatment to disease progression or death due to any cause
Time Frame
up to approximately 24 months
Title
Overall Survival (OS)
Description
OS, defined as time from date of treatment to death due to any cause
Time Frame
up to approximately 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 ≤ age ≤ 75 years old, male or female is not limited; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 Life expectancy of ≥ 12 weeks Pathologically confirmed advanced pancreatic cancer defined as non-operable in a curative intent, locally recurrent, or metastatic disease.
Exclusion Criteria:
adjuvant treatment with gemcitabine within 6 months prior to the first dose; Radiotherapy and anti-cancer Chinese patent medicine treatment were performed within 4 weeks before the first dose; Gastrointestinal diseases that could affect the absorption of Z650, (e.g., serious swallowing obstruction, chronic diarrhea, bowel obstruction); Doppler ultrasound evaluation of Left ventricular ejection fraction < 50%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
shu zhang
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
lianke liu
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
China/jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
shandong Cancer Hospital
City
Jinan
State/Province
China/shandong
ZIP/Postal Code
250117
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Gemcitabine and Z650 in Treating Patients With Metastatic or Recurrent Pancreatic Cancer
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